Phase II Study of SCH66336, A Farnesyltransferase Inhibitor in Chronic Myelogenous Leukemia (CML)

Myelogenous Leukemia, Chronic Clinical Trial

Official title:

Phase II Study of SCH66336, A Farnesyltransferase Inhibitor in Chronic Myelogenous Leukemia (CML)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00038597
• Other study ID #: DM01-072
• Status: Completed
• Phase: Phase 2
• Start date: April 30, 2001
• Est. completion date: May 7, 2004

Study information

• Verified date: October 2018
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this research is to see if giving the drug SCH66336 by mouth can improve the disease in patients with chronic or accelerated phase CML. The safety of this treatment will also be studied.

Description:

Objectives for this study are two-fold:

1. To determine the efficacy of SCH66336 in patients with chronic phase and accelerated phase CML in relation to response rate, duration of response, and survival.

2. To assess the toxicity of SCH66366 in these patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: May 7, 2004
• Est. primary completion date: May 7, 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

• Diagnosis of Philadelphia chromosome (Ph) -positive CML in chronic or accelerated phase;

• Failure to respond to or intolerance to imatinib mesylate (Gleevec);

• Age >/= 16 years;

• Life expectancy of >/= 2 months;

• Performance status 2 or better (Zubrod);

• Adequate renal and hepatic functions (creatinine and bilirubin </= 2 mg/dl);

• Adequate cardiac function;

• Not candidates for or have refused allogeneic transplantation;

• Patients should not be receiving azoles (ketoconazole, itraconazole, fluconazole), macrolides, HIV protease inhibitors, cyclosporin or anti-seizure drugs (phenobarbital, phenytoin, carbamazepine), rifampin or isoniazid.

Related Conditions & MeSH terms

• Chronic Disease
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Myelogenous Leukemia, Chronic

Intervention

Drug:
• SCH66336

Locations

Country	Name	City	State
United States	MDAnderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

External Links

•   UT MD Anderson Cancer Center Website